Molecular biology advances in the last decade gave great promise for the introduction of new, sensitive technologies to identify various analytes in test specimens, including the ability to diagnose cancer, infectious agents and inherited diseases. Clinical molecular diagnostics depend almost exclusively on restriction enzyme analyses and nucleic acid hybridization (Southern and Northern blots) (Meselson and Yuan, 1968, Southern, 1975). Clinical tests based on molecular biology technology are more specific than conventional immunoassay procedures and can discriminate between genetic determinants of two closely related organisms. With their high specificity, nucleic acid procedures are very important tools of molecular pathology. However, nucleic acid procedures have limitations, the most important of which are the procedures consume time, are labor intensive and have low sensitivity (Nakamura 1993).
There exists a need to perform analytical and diagnostic assays of high sensitivity and high specificity. There exists a need for analytical methods, compositions and devices which facilitate the performance of a analytical or diagnostic procedure in less than one hour. There exists a need for analytical methods, compositions and devices which are directed to targets which are present in cells in quantities greater than one to one thousand copies. There exists a need for analytical and diagnostic procedures which identify small or large organic molecules, peptides or proteins, the tertiary structure of nucleic acids or complex or simple carbohydrates.